Doral is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) that is used to treat insomnia (trouble falling or staying asleep).

Doral may also be used for purposes not listed in this medication guide.

Doral can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol.

MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Do not stop using Doral without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use. Some withdrawal symptoms may last up to 12 months or longer.

Get medical help right away if you stop using Doral and have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, or thoughts about suicide.

Do not use if you are pregnant.

Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use Doral in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of Doral.

Never share this medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

When you first start taking Doral, you may need to cut the tablet in half to get the correct dose. Follow your doctor's dosing instructions carefully.

Take this medicine only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Call your doctor if your insomnia does not improve after taking Doral for 7 to 10 nights, or if you have any mood or behavior changes. Insomnia can be a symptom of depression, mental illness, or certain medical conditions. Do not take this medicine for longer than 10 nights in a row, unless your doctor has told you to.

Do not stop using Doral without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use.

Store at room temperature away from moisture and heat. Keep your medicine in a place where no one can use it improperly.

• Your insomnia symptoms may return when you stop using Doral after using it over a long period of time.

You should not use Doral if you are allergic to it, or if you have:

• a chronic breathing disorder;

• sleep apnea (breathing stops during sleep); or

• an allergy to sleep medicine or to other benzodiazepines (such as alprazolam, diazepam, lorazepam, midazolam, Ativan, Valium, Tranxene, Versed, Xanax, and others).

May cause birth defects. Do not use if you are pregnant. If you use Doral during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks. Use effective birth control while using this medicine. Tell your doctor if you become pregnant.

Tell your doctor if you have ever had:

• breathing problems;

• drug or alcohol addiction;

• suicidal thoughts or actions;

• depression or mental illness; or

• liver or kidney disease.

Do not breastfeed.

Not approved for use by anyone younger than 18 years old.

Doral is used when needed. If you are on a dosing schedule, skip any missed dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of quazepam can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing.

• Overdose symptoms may include extreme drowsiness, confusion, or coma.

Overdose symptoms may include drowsiness, confusion, slurred speech, weak or shallow breathing, or coma.

Do not drink alcohol while taking Doral or for several days after you stop taking Doral.

You may still feel sleepy the morning after taking this medicine. Wait until you are fully awake before you drive, operate machinery, or do anything that requires you to be awake and alert. Your reactions may be impaired.

Doral may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; nausea, vomiting; swelling of your face, lips, tongue, or throat.

Doral can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Doral may cause serious side effects. Call your doctor at once if you have:

• confusion, agitation, hallucinations;

• unusual thoughts or behavior;

• suicidal thoughts; or

• worsening depression.

Some people using Doral have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. Tell your doctor if this happens to you.

Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.

Common side effects of Doral may include:

• drowsiness, dizziness;

• headache;

• feeling tired;

• dry mouth; or

• upset stomach.

After you stop using Doral, get medical help right away if you have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, suicidal thoughts or actions.

Some withdrawal symptoms may last up to 12 months or longer after stopping Doral suddenly. Tell your doctor if you have ongoing anxiety, depression, problems with memory or thinking, trouble sleeping, ringing in your ears, a burning or prickly feeling, or a crawling sensation under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using Doral with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect Doral, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.